80 Participants Needed

BCI-Controlled Robotic Exoskeleton for Stroke

KC
LS
Overseen ByLauren Souders, MOT, OTR/L
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Neurolutions, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a remote therapy that helps stroke patients move their hands using brain signals to control a robotic device. It targets patients with ongoing movement difficulties on one side of their body. The system works by detecting brain signals and moving a robotic hand to aid in motor skill improvement.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 who have had a stroke and now experience weakness or paralysis in one arm. They should not be receiving other upper extremity therapies, have severe cognitive impairments, contractures that prevent device use, certain communication difficulties, or conditions affecting pain sensation.

Inclusion Criteria

I have had a stroke.
I am not receiving Botox for my arm, or if I am, it's scheduled around the training start.
I have weakness or paralysis in one arm.

Exclusion Criteria

I can feel pain and do not have nerve or sensory issues that affect this.
You have trouble understanding and following written instructions or have a low score on a language test.
Participants who are pregnant or breast-feeding will be excluded.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
Remote EEG screening

Treatment

Participants receive either the IpsiHand BCI system or a standard home exercise program for 12 weeks

12 weeks
Daily virtual monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • IpsiHand Device
Trial Overview The study compares the effectiveness of a home-based brain-computer interface therapy using the IpsiHand System against standard exercises for improving arm function after stroke. Participants will either use the BCI-controlled robotic hand exoskeleton at home or follow an exercise program.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Standard of Care - Home Exercise Program for Upper ExtremityExperimental Treatment1 Intervention
Group II: BCI treatment Group using the IpsiHandExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Neurolutions, Inc.

Lead Sponsor

Trials
4
Recruited
160+

Washington University School of Medicine

Collaborator

Trials
2,027
Recruited
2,353,000+
Unbiased ResultsWe believe in providing patients with all the options.
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